Lactase to help weight gain in premature infants
A Randomized, Double-blind, Patient-control Trial to Study Weight Gain in Premature Newborns Receiving Lactase-fortified Milk
We will try giving lactase to premature newborns born at 28–34 weeks who receive at least 75% of their nutrition enterally to see if it helps them gain weight.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 1 Day to 4 Weeks |
| Sex | All |
| Sponsor | Aristotle University Of Thessaloniki Academic / other |
| Locations | 2 sites (Thessaloniki and 1 other locations) |
| Trial ID | NCT07150884 on ClinicalTrials.gov |
What this trial studies
This interventional study gives oral lactase enzyme to premature infants (28–34 weeks gestation) who are receiving ≥75% of their nutrition enterally. Eligible infants without major congenital or gastrointestinal disease will receive lactase with feeds and be monitored during their neonatal hospitalization. The study records weight gain, feeding tolerance, and related clinical outcomes. Outcomes will be compared with standard care to see if lactase supplementation improves growth or reduces feeding-related symptoms.
Who should consider this trial
Good fit: Premature infants born at 28–34 weeks who receive at least 75% of their energy enterally and do not have major congenital or gastrointestinal disease or recent postnatal steroid/diuretic therapy.
Not a fit: Infants with congenital malformations, necrotizing enterocolitis, those receiving postnatal steroids or diuretics, or those not predominantly enterally fed are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, lactase supplementation could improve weight gain and reduce feeding intolerance in some premature infants, supporting better early growth and shorter hospital stays.
How similar studies have performed: Small prior studies have reported benefits from lactase-supplemented or reduced-lactose formulas in premature infants, but the evidence is limited and not definitive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: The study will enrol newborns (1) with a gestational duration of 28 to 34 weeks, (2) who receive ≥75% of their energy needs intestinally, (3) with the absence of severe congenital malformations or gastrointestinal diseases, including necrotizing enterocolitis (NEC) (4) without taking postnatal steroids or diuretics. Small, suitable and large for newborns of gestational age will be eligible for the study. Exclusion Criteria: Exclusion criteria will be neonates whose guardians refuse to participate in the study, neonates with congenital malformations or gastrointestinal diseases, and neonates receiving postnatal steroids or diuretics.
Where this trial is running
Thessaloniki and 1 other locations
- Papageorgiou General Hospital — Thessaloniki, Greece (Active_not_recruiting)
- Papageorgiou General Hospital — Thessaloniki, Greece (Recruiting)
Study contacts
- Study coordinator: Dimitrios Rallis
- Email: drallis@auth.gr
- Phone: +30231332 3323
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.